Rapid Acting Transcranial Magnetic Stimulation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Treatment Resistant Depression
- Sponsor
- Stanford University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Rates of remission one month after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.
- Status
- Active, Not Recruiting
- Last Updated
- 12 months ago
Overview
Brief Summary
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In a double-blind, randomized, sham-controlled fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been effective in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session, 5 days per week, for 4-8 weeks). Recently, we have pursued modifying the treatment parameters to reduce treatment times with an accelerated treatment paradigm with great preliminary success. This study aims to further study our accelerated protocol and examine changes in neuroimaging biomarkers.
Investigators
David Spiegel
Professor, Department of Psychiatry and Behavioral Sciences, Stanford University
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Male or Female, between the ages of 22 and 65 at the time of screening.
- •Able to read, understand, and provide written, dated informed consent prior to screening.
- •Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
- •Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
- •Medical records confirming a history of moderate to severe treatment-resistance as defined by a score of 7-14 on the Maudsley Staging Method (MSM 3).
- •MADRS score of ≥20 at screening (Visit 1).
- •Access to ongoing psychiatric care before and after completion of the study.
- •Access to clinical rTMS after study completion.
- •Must be on a stable antidepressant therapeutic regimen for 6 weeks prior to study enrollment and agree to continue this regimen throughout the study period.
- •In good general health, as evidenced by medical history.
Exclusion Criteria
- •Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder
- •History of or current psychotic disorder or bipolar disorder
- •Severe borderline personality disorder.
- •Diagnosis of Intellectual Disability or Autism Spectrum Disorder
- •Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
- •Urine screening test positive for illicit substances
- •Active suicidal ideation (defined as an MSSI \> 8) or a suicide attempt (as defined by the C-SSRS) within the past one year
- •Any history of ECT (greater than 8 sessions) without meeting responder criteria
- •Recent (within 4 weeks of any clinical effect) or concurrent use of rapid acting antidepressant agent (i.e., ketamine or a course of ECT)
- •History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma
Outcomes
Primary Outcomes
Rates of remission one month after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.
Time Frame: Baseline, 1-month.
The Montgomery-Åsberg Depression Rating Scale (MADRS), is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Remission is defined as MADRS ≤10.
Secondary Outcomes
- Rates of response one month after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.(Baseline, 1-month.)